12 results
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20ms
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Sources: EU EUDAMED, US FDA
HORIZON 2000 TRANSCUTANEOUS GAS MONITORING
FDA 510(k)
FDA Class 2
·Anesthesiology
P.F.C.
FDA UDI
DEPUY (IRELAND)·10603295215455·P.F.C. TIBIAL TRAY FIXED BEARING MODULAR PLUS 4...
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011860124000·Standard Band, Tooth 15-14/24-25, Size 24
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011860124180·Standard Band, Tooth 15-14/24-25, Size 24/Roth 18
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011860124220·Standard Band, Tooth 15-14/24-25, Size 24/Roth 22
ATRIUM FLIXENE GRAFT
FDA 510(k)
FDA Class 2
·Cardiovascular
LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MOD M00565010
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - GALWAY·Product code MUM·October 7, 2010
MESH - VENTRALEX
FDA Adverse Event
Injury
·DAVOL INC·Product code FTL·November 29, 2012
CAPSUREFIX MRI SURESCAN
FDA Adverse Event
Injury
·MPRI·Product code NVN·June 10, 2014
Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·October 1, 2025
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012